NARAMIN- diphenhydramine hydrochloride solution

NARAMIN Antihistamine Oral Solution
Active ingredient (per 5 ml = one pre-filled whistle)*

Diphenhydramine HCl 12.5 mg
Purpose

Antihistamine
Uses
For the temporary relief of these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
Warnings
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- a sodium-restricted diet
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you

are taking sedatives or tranquilizers

When using this product

marked drowsiness may occur

avoid alcoholic beverages

alcohol, sedatives, and tranquilizers may increase the drowsiness effect

use caution when driving a motor vehicle or operating machinery

excitability may occur, especially in children

Choking Hazard: Small parts. Keep out of reach of children.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Adults and children 12 years of age and over	Take 2-4 pre-filled whistles every 4 to 6 hours, not to exceed 24 whistles in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age	Take 1-2 pre-filled whistles every 4 to 6 hours, not to exceed 12 whistles in 24 hours, or as directed by a doctor
Children under 6 years of age	Consult a doctor

Other information
- Each pre-fille whistle contains 14 mg of sodium
- Protect from light.
- SAFETY SEALED: This product is protected by a sealed pouch. Do not use if individual foil pouch is torn or damaged.
- Whistle is not child resistant. Do not remove whistle from child resistant foil pouch prior to use.
- Store between 68 degrees-77 degrees F (20 degrees - 25 degrees C)
- Store in outer carton until contents are used.
Inactive ingredients

anhydrous citric acid, DandC red no. 33, FDandC red no.40, flavor, glycerin, monoammonium glycyrrhizinate, poloxamer 407, sodium benzoate, sodium chloride, sodium citrate, sucrose, water
Questions or comments?

1-855-251-0106
NARAMIN Antihistamine Oral Solution 10-5ml whistles (58292-010-05)

NARAMIN
diphenhydramine hydrochloride solution

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	05/28/2014

Labeler - National Pharma Industries Inc (078725867)

Name	Address	ID/FEI	Business Operations
Establishment
Plastikon Healthcare, LLC		041717941	manufacture(58292-010)

NARAMIN by